Dosing and uses of Kalbitor (ecallantide)
Adult dosage forms and strengths
injectable solution
- 10mg/mL per single-use vial
Hereditary Angioedema (Acute Attacks)
30 mg (3 mL) SC administered in 3 separate 10 mg (1 mL) injections
If attack persists, may administer an additional dose of 30 mg within 24 hr
Pediatric dosage forms and strengths
injectable solution
- 10mg/mL per single-use vial
Hereditary Angioedema (Acute Attacks)
<12 years: Safety and efficacy not established
≥12 years: As adults; 30 mg (3 mL) SC administered in 3 separate 10 mg (1 mL) injections
If attack persists, may administer additional 30 mg dose within 24 hr
Kalbitor (ecallantide) adverse (side) effects
>10%
Headache (16.1%)
Nausea (12.9%)
Fatigue (11.8%)
Diarrhea (10.6%)
1-10% (selected)
Upper respiratory tract infection (8.2%)
Nasopharyngitis (5.9%)
Vomiting (5.5%)
Pruritus (5.1%)
Upper abdominal pain (5.1%)
Pyrexia (4.7%)
Anaphylaxis (3.9%)
Injection site reactions
Rash
Urticaria
Warnings
Boxed Warning
Anaphylaxis has been reported in 3.9% of treated patients
Because of risk for anaphylaxis, administered by healthcare professional only with medical support
Healthcare professionals should be aware of similarity of symptoms between anaphylaxis and angioedema
Do not administer to patient with known hypersensitivity to ecallantide
Symptoms have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension
Pruritus, rash, and urticaria may also indicate hypersensitivity
These reactions occurred within the first hour after dosing
Contraindications
Hypersensitivity
Pregnancy and lactation
Pregnancy category: C
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Kalbitor (ecallantide)
Mechanism of action
Human plasma kallikrein inhibitor, thereby reducing conversion of kininogen to bradykinin; bradykinin production may contribute to increased vascular permeability and angioedema experienced in HAe
Pharmacokinetics
Half-life: 2 hr
Vd: 26.4 L
Peak plasma time: 2-3 hr
Peak plasma concentration: 586 +/- 106 ng/mL
Clearance: 153 mL/min
Administration
Instructions
Because of risk for anaphylaxis, administered by healthcare professional only with medical support
Inject in thigh, abdomen, or upper arm
